M Rodríguez1, J A Rubio, R Sanchez. 1. Facultad de Odontología, Universidad Nacional de Colombia, Bogotá, Colombia. mrodriguezgo@unal.edu.co
Abstract
OBJECTIVE: To compare the effectiveness of two topical medications to reduce the pain and size of recurrent minor aphthous ulcers. SETTING:Ten Colombian Dental Faculties' clinics. DESIGN: A double-blind randomized multi-centre clinical study. SUBJECTS:Ninety-six patients complaining of at least five acute aphthous ulcers were randomized to two intervention groups. Sample size was calculated using an alpha error of 0.05 and beta of 0.20. MATERIALS AND METHODS: Participants were randomly assigned to receive 5% amlexanox or a 0.05% clobetasol propionate magistral preparation. Observers at the participating institutions were previously trained to standardize clinical diagnosis and data recollection. Ulcer size and pain were measured on treatment days 0, 2 and 5. RESULTS: No significant differences were found between the two groups studied in any of the studied variables at baseline. Both treatment medications significantly reduced pain magnitude and the index ulcer's size on days 2 and 5 compared with day 0 without adverse reactions (within groups differences). No statistical differences between groups of the study medications were found. CONCLUSION: The two treatments applied had similar effectiveness as they both relieved pain and reduced the size of recurrent aphthous ulcers.
RCT Entities:
OBJECTIVE: To compare the effectiveness of two topical medications to reduce the pain and size of recurrent minor aphthous ulcers. SETTING: Ten Colombian Dental Faculties' clinics. DESIGN: A double-blind randomized multi-centre clinical study. SUBJECTS: Ninety-six patients complaining of at least five acute aphthous ulcers were randomized to two intervention groups. Sample size was calculated using an alpha error of 0.05 and beta of 0.20. MATERIALS AND METHODS:Participants were randomly assigned to receive 5% amlexanox or a 0.05% clobetasol propionate magistral preparation. Observers at the participating institutions were previously trained to standardize clinical diagnosis and data recollection. Ulcer size and pain were measured on treatment days 0, 2 and 5. RESULTS: No significant differences were found between the two groups studied in any of the studied variables at baseline. Both treatment medications significantly reduced pain magnitude and the index ulcer's size on days 2 and 5 compared with day 0 without adverse reactions (within groups differences). No statistical differences between groups of the study medications were found. CONCLUSION: The two treatments applied had similar effectiveness as they both relieved pain and reduced the size of recurrent aphthous ulcers.
Authors: L Baccaglini; R V Lalla; A J Bruce; J C Sartori-Valinotti; M C Latortue; M Carrozzo; R S Rogers Journal: Oral Dis Date: 2011-08-04 Impact factor: 3.511